Fluidx Submits Final PMA Module to FDA for the GPX Embolic Device

July 24, 2026—Fluidx Medical Technology, Inc. announced that the final module of its premarket approval (PMA) application for the company’s GPX embolic device has been submitted to the FDA.

According to the company, the final PMA module contained the results from the pivotal investigational device exemption clinical trial of GPX that included more than 40 investigators who enrolled 114 patients at 18 sites across the United States, Canada, and New Zealand. Previous modules that the FDA has already reviewed contained the preclinical testing and manufacturing components of the submission.

Fluidx recently announced the results of the pivotal trial. Pathologies treated in the trial included prenephrectomy renal arteries, primary and metastatic bone tumors, renal cell carcinoma, hepatocellular carcinoma, renal angiomyolipoma, portal vein branches, and other vascular tumor or tumor metastases.

The data were presented this spring at the SIR 2026 and GEST meetings. The late-breaking abstract of the study results was published in Journal of Vascular and Interventional Radiology.

In the pivotal trial, GPX was delivered through more than 20 different microcatheter configurations spanning outer diameters from 1.9- to 2.8-F and lengths from 110 to 165 cm, demonstrating broad compatibility with a wide range of commonly used delivery devices, the company stated.